Z-0096-2024Class II

GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290

Name: Z-0096-2024 GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
Creator: Ansell Healthcare Products LLC
Published: 2023-08-03
License: https://open.fda.gov/license/

Ansell Healthcare Products LLC / initiated 2023-08-03 / Open, Classified / root cause: manufacturing process

FDA source

Ansell Healthcare Products LLC began a recall of GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 on 2023-08-03. FDA classified it as Class II and gives the reason as "Some surgical glove sterile pouches were not completely sealed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0096-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-03
Posted: 2023-10-11
Recalling firm: Ansell Healthcare Products LLC
Product: GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
Product code: KGO Surgeon'S Gloves
Reason for recall: Some surgical glove sterile pouches were not completely sealed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 8/3/23, recall notices were mailed or emailed to customers and distributors. Customers who did not respond were contacted via phone. Customers and distributors were asked to do the following: 1) Communicate with all personnel that utilize the product of the risk of and need to discontinue use of the impacted products. 2) Complete the customer Response Form at http://www.novasyte.com/ansell/capa-296-2023 and 3) Return impacted product. If impacted product was purchased from a distributor, contact your distributor directly for further instructions and replacement products. Customers with questions can call 1-800-952-9916 or email [email protected] In addition, distributors were asked to take every effort to communicate the recall situation to their impacted End-User customers that received this product. We recommend that distributors attempt to contact and notify each customer at least three times by e-mail and/or by phone. See end-user customer letters. Please contact Novasyte with questions via email [email protected] or at (855) 558-2741. visit http://www.novasyte.com/ansell/capa-296-2023 to complete the necessary acknowledgement form If you have questions on this notification, please reach out directly via [email protected] or 1-800-952-9916.
Quantity in commerce: 1511
Distribution: Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.
Product codes and lots: Lot: 2203434204, REF/UDI-DI: 20685255/00884792385206, 20685260/00884792385213, 20685265/00884792385220, 20685270/00884792385237, 20685275/00884792385244, 20685280 00884792385251, 20685285 00884792385268, 20685290 00884792385275.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0096-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0096-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-11
Z-0097-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-11

Product code KGO

K111139Class IDerma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for UAnsell Healthcare Products, Inc. / cleared 2011-09-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)